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Compensation package for clinical trial victims in the offing

NEW DELHI:
India will soon quantify the amount of compensation to be paid by
pharmaceutical companies, if a volunteer dies or gets injured during a clinical
trial.

On October 10,
the Drug Technical Advisory Board (DTAB) gave its nod to the Central Drugs
Standard Control Organization (CDSCO) to prepare a "compensation
chart" or extensive guidelines that will specify the amount to be paid.

Ethical
committees of the company will have to decide the quantum of compensation on
the basis of these guidelines.

The
compensation has to be paid by the trial's sponsor or its representative within
90 days of the death or injury to the victim or the next of h/his kin. In the
first 30 days, the firm will have to prove to the ethics panel that the death
or injury wasn't due to the drug, else it has to pay.

In India,
pharma companies pay compensation "according to their will" that
varies between Rs 1 lakh and Rs 10 lakhs since "no set parameters have
been laid down".

The CDSCO will
prepare the compensation guidelines after consulting the Motor Vehicles Act,
Railways and the Workers Compensation Act.

Union health
ministry officials say it will take another three months to notify the
guidelines. "When a 70-year-old terminally ill patient dies during a
clinical trial, the compensation should be less than that given to a
22-year-old in the first stage of the same ailment. The youngster could be the
family's sole bread-winner and would have lived longer had it not for the
adverse drug reaction. The guidelines will quantify who should get how much
compensation," a ministry official told TOI.

"Both
these patients could get the same amount. However, the pharma company might
have decided on an abysmally low package. Once the guidelines are in place, the
division of compensation will be fair," he added.

Families of the
22 clinical trial victims last year were paid around Rs 50 lakh by 10 pharma
companies.

Compensation
ranged from Rs 1.08 lakh to Rs 10 lakh. Most of the families received Rs 1.5
lakh and Rs 2.5 lakh as a one-time package.

Initially, the
companies had not paid compensation for majority of these deaths. Then, DCGI Dr
Surinder Singh issued an ultimatum to the errant firms: pay up or all other
trials would be suspended.

The companies
who paid the compensation included well-known names like Wyeth, Quintiles,
Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer. Pharma
companies have all along been blamed for not paying compensation to hapless
clinical trial victims.

The Indian
Council of Medical Research recently framed draft guidelines for compensation
to participants for research-related injury. Mothers, who because of clinical
trials, lose or cause harm to their unborn child may be able to demand
compensation from researchers conducting the trials.

Compensation
has to be paid, irrespective of whether injury was foreseeable/predictable, and
that the research participant had freely consented in writing about
participating in it.

Compensation
will have to be provided to the research participants when temporary or
permanent injury occurs due to participation in the clinical study.

Compensation
also has to be paid when the injury is caused by a procedure that has been
undertaken to manage an adverse reaction occurring during the research.

Defining
"compensation", the draft says it could be in form of payment for
immediate medical/surgical management of research-related injuries,
compensation for research-related injuries leading to temporary or permanent
disabilities or compensation to legal heir/lawful guardian in case of death.

"The
payment will be the responsibility of the investigator/institution," it
says.

Besides, the
Informed Consent Document (ICD) will have to state that the research participant
has the right to claim compensation in case of research-related injuries and
whom to contact for it.

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